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The Nitazoxanide Plus Atazanavir for COVID-19 Study

NCT04459286 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2022-03-02

No results posted yet for this study

Summary

Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans.

In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days.

The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.

Conditions

Interventions

DRUG

Nitazoxanide and atazanavir/ritonavir

1000 mg nitazoxanide tablets twice daily and 300/100 mg atazanavir/ritonavir tablets once daily with meal

OTHER

Standard of Care

SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19

Sponsors & Collaborators

  • University of Liverpool

    collaborator OTHER

  • African Centre of Excellence for Genomics of Infectious Diseases

    collaborator UNKNOWN

  • Infectious Disease Hospital Olodo

    collaborator UNKNOWN

  • Obafemi Awolowo University Teaching Hospitals Complex

    collaborator UNKNOWN

  • Osun State Ministry of Health

    collaborator UNKNOWN

  • Olabisi Onabanjo University Teaching Hospital

    collaborator UNKNOWN

  • Obafemi Awolowo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2021-05-02
Completion
2021-05-02

Countries

  • Nigeria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04459286 on ClinicalTrials.gov